Prosoria Scalp Lotion/shampoo
FDA Label NDC 71573-116

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvothera, Inc. for the product Prosoria Scalp (NDC 71573-116). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Nuvothera, Inc.
Fort Worth, Texas 76104

Active Ingredient

Salicylic acid, 1.8%

Purpose

Antipsoriasis, antiseborrheic

Uses

relieves and helps prevent recurrence of symptoms of psoriasis and/or seborrheic dermatitis including:

  • scaling
  • flaking
  • itching
  • redness
  • irritation

Warnings

For external use only

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and consult a doctor if the condition worsens or does not improve after regular use of this product as directed.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply and massage well on affected areas of the scalp once daily or as directed by a doctor. Tip bottle and apply small drops to affected area of the scalp and spread evenly. Let dry and leave on. Shampoo hair when needed.

Other Information

  • store at room temperature 59-77°F (15-25°C).

Inactive Ingredients

Water, Petrolatum, Ethoxydiglycol, Oleth-3 Phosphate, Butylene Glycol, Tetrahydrodiferuloylmethane, Polyacrylate Crosspolymer-6, Sodium Hydroxide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Curcuma Longa (Turmeric) Root Extract, Nigella Sativa Seed Oil, Polyisobutene, Cyclodextrin, Undecylenoyl Glycine, Phenoxyethanol, Capryloyl Glycine, Disodium EDTA, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid.

Questions?

Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.

Principal Display Panel - 74 Ml Bottle Label

treats

prosoriä

scalp lotion

1.8% salicylic acid

anti-psoriasis
anti-seborrheic

2.5 FL OZ (74mL)

Principal Display Panel (74 mL Bottle Label)

Principal Display Panel (74 mL Bottle Label)

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